To confirm the clinical efficacy of Serostim compared with placebo, based on an endpoint of exercise function change.

Secondary Outcome Measures:

To establish an optimal dose of Serostim, based on the endpoint of lean body mass (LBM) change.

Study Start Date:

July 1997

Study Completion Date:

March 2002

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Criteria

Inclusion Criteria:

Have clearly documented HIV infection, determined by the presence of HIV confirmed by one of the following: Western blot, immunofluorescence assay, HIV culture, polymerase chain reaction (PCR) amplification, branched DNA (bDNA) signal amplification or the presence of p24 antigen. These tests may have been performed at any time in the past, but the results must be available for review by Serono prior to entry into the study.

Have evidence of AIDS wasting, with at least one of the following:

Documented unintentional weight loss of at least 10%, or

In the absence of unintentional weight loss of 10%, weight less than 90% of ideal body weight (Metropolitan Height and Weight Tables), or

Patients with acute critical illnesses in intensive care units due to complications following open heart or abdominal surgery, multiple accidental trauma, or with acute respiratory failure.

Either of the following aspects of the medical regimen in the 30 days prior to study entry (60 days prior to receiving study drug):

New systemic therapy for opportunistic infection.

New therapy for wasting, including parenteral or oral hyperalimentation, tube feeding, anabolic or progestational agents, or appetite stimulants.

Prior radiation therapy or systemic chemotherapy.

Use of glucocorticoids within the past six months or growth hormone within the past year.

An untreated or suspected serious systemic infection, or persistent fever > 101°F (or 38.5°C) during the 30 days prior to study entry.

Evidence of gastrointestinal (GI) bleeding, obstruction, or malabsorption as determined by the Investigator.

Active substance abuse which would prevent informed consent or compliance with study activities.

Dementia which would preclude the patient from giving informed consent or complying with the requirements of this protocol.

If female, be neither pregnant or breast feeding.

Use of an investigational agent under another protocol unless discussed and approved in advance by Serono's Therapeutic Director.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489528